Treatment of Complex Pilon Fractures

Treatment of Complex Pilon Fractures: A Pilot Study Comparing Primary Arthrodesis (PA) to Open Reduction and Internal Fixation (ORIF)

This project intends to compare patient outcomes between patients undergoing ORIF compared to PA, or ankle fusion, following an acute pilon fracture. Limited literature comparing ORIF and ankle fusion as a primary procedure exists. Particularly, no present literature exists examining the novel arthrodesis surgical technique utilized in this study in conjunction with Opal sensor gait analysis data. This study will serve as a pilot study and assess patient gait, degree of pain, functional outcome scores, development of post-traumatic arthritis and/or infection, need for secondary surgery, and return to work time.

Study Overview

• Status: Recruiting
• Conditions: Pilon Fracture

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Brent Wise, MD; Phone Number: 913-588-6164; Email: bwise3@kumc.edu
• Study Contact Backup: Name: David Turkowitch, BS; Email: dturkowitch@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66103
      • Recruiting
      • The University of Kansas Medical Center
      • Contact: Dave Turkowitch, BS; Email: dturkowitch@kumc.edu
      • Principal Investigator: Brent Wise, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals over the age of 18 that have undergone an ORIF or PA surgery for an acute pilon fracture at either KUMC or Emory University Hospital.

Description

Inclusion Criteria: Individuals receiving ORIF or PA for a multifragmented acute pilon fracture occuring at the joint surface over the age of 18 from 2018 to present at The University of Kansas Medical Center (KUMC) or Emory University Hospital.

Exclusion Criteria: Anyone under the age of 18 years. Pregnant women.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Open reduction and internal fixation (ORIF); Patient has underwent ORIF to repair a pilon fracture.
Primary arthrodesis (PA; ankle fusion); Patient has underwent PA/ankle fusion to repair a pilon fracture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ankle range of motion	Inversion and eversion range, and flexion versus extension range determined by the use of the Opal sensors	Collected only once; from 6 months post-op up to date of death from any cause
Walking cadence	Steps per minute as determined by the use of the Opal Sensors	Collected only once; from 6 months post-op up to date of death from any cause
Timed up-and-go	Time it takes to stand from seated, walk 10 feet forward, turn around, and sit back down, unassisted (determined by the use of the Opal sensors).	Collected only once; from 6 months post-op up to date of death from any cause
Foot and ankle Outcome Score (FAOS)	Foot and ankle injury patient reported outcome measure (Scores range from 0 to 100, with higher scores indicating better foot and ankle surgical outcomes)	Collected only once; from 6 months post-op up to date of death from any cause
12 Item Short Form Survey (SF-12)	Patient reported outcome measures regarding health and daily activities (Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning)	Collected only once; from 6 months post-op up to date of death from any cause

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of infection and/or post-traumatic arthritis	Rate of patients being rehospitalized or returning for care beyond what is required due to infection or arthritis	From the date of surgery up until the date of death from any cause
Need for secondary operation	Number of patients that required follow up surgery to their initially injured ankle	From the date of surgery up until the date of death from any cause
Return to work time	Number of weeks it took for patients to return to work	From the date of surgery up until the date of death from any cause

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: Emory University

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2023
• Primary Completion (Estimated): December 25, 2023
• Study Completion (Estimated): December 25, 2023

Study Registration Dates

• First Submitted: September 13, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Pilon Fracture
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 00150446